NCT06046781

Brief Summary

Physical therapy and rehabilitation may improve low back pain and quality of life after lumbar disc herniation. But there is not any agreement of its optimal start time, and rehabilitative methods. This study evaluates the effects of early and late rehabilitation to the low back pain and quality of life following unilateral microdiscectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
204

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 7, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

5 months

First QC Date

September 13, 2023

Last Update Submit

September 19, 2023

Conditions

Keywords

Lumbar disc herniationLumbar microdiscectomyphysical exercise

Outcome Measures

Primary Outcomes (1)

  • Affect on back pain

    Different effects of early and late rehabilitation to the low back pain following unilateral microdiscectomy. Pain status will be evaluated with the Visual Analogue Scale.

    0 - 1 Months in the post-operative period

Study Arms (5)

Control group

OTHER

One group served as the control and was advised not to participate in any postoperative exercise.

Other: physical exercise

Second week walking group

EXPERIMENTAL

Postoperative walking initiated 2 weeks following surgery.

Other: physical exercise

One month walking group

EXPERIMENTAL

Postoperative walking initiated one month following surgery.

Other: physical exercise

Second week waist exercise group

EXPERIMENTAL

Postoperative waist exercise initiated 2 weeks following surgery.

Other: physical exercise

One month waist exercise group

EXPERIMENTAL

Postoperative waist exercise 1 month following surgery.

Other: physical exercise

Interventions

The patients were randomized into 5 groups as control group, walking at 2 weeks, walking at 4 weeks, waist exercise at 2 weeks, waist exercise at 4 weeks.

Control groupOne month waist exercise groupOne month walking groupSecond week waist exercise groupSecond week walking group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • radicular pain that persisted despite 4-6 weeks of conservative treatment,
  • detection of single-level disc herniation in MRI lumbar microsurgery.
  • Individuals who underwent single-level unilateral lumbar microsurgery. Those with a surgical incision \<3 cm.

You may not qualify if:

  • Individuals with more than one level of muscle exposure at the time of surgery.
  • those with a skin incision \>3 cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medeniyet University Medical Faculty Goztepe Suleyman Yalcin City Hospital

Istanbul, Kadıkoy, 34722, Turkey (Türkiye)

Location

Related Publications (10)

  • Kim YK, Kang D, Lee I, Kim SY. Differences in the Incidence of Symptomatic Cervical and Lumbar Disc Herniation According to Age, Sex and National Health Insurance Eligibility: A Pilot Study on the Disease's Association with Work. Int J Environ Res Public Health. 2018 Sep 25;15(10):2094. doi: 10.3390/ijerph15102094.

    PMID: 30257414BACKGROUND
  • Hlubek RJ, Mundis GM Jr. Treatment for Recurrent Lumbar Disc Herniation. Curr Rev Musculoskelet Med. 2017 Dec;10(4):517-520. doi: 10.1007/s12178-017-9450-3.

    PMID: 29103156BACKGROUND
  • Huang W, Han Z, Liu J, Yu L, Yu X. Risk Factors for Recurrent Lumbar Disc Herniation: A Systematic Review and Meta-Analysis. Medicine (Baltimore). 2016 Jan;95(2):e2378. doi: 10.1097/MD.0000000000002378.

    PMID: 26765413BACKGROUND
  • Lewis RA, Williams NH, Sutton AJ, Burton K, Din NU, Matar HE, Hendry M, Phillips CJ, Nafees S, Fitzsimmons D, Rickard I, Wilkinson C. Comparative clinical effectiveness of management strategies for sciatica: systematic review and network meta-analyses. Spine J. 2015 Jun 1;15(6):1461-77. doi: 10.1016/j.spinee.2013.08.049. Epub 2013 Oct 4.

    PMID: 24412033BACKGROUND
  • Rasouli MR, Rahimi-Movaghar V, Shokraneh F, Moradi-Lakeh M, Chou R. Minimally invasive discectomy versus microdiscectomy/open discectomy for symptomatic lumbar disc herniation. Cochrane Database Syst Rev. 2014 Sep 4;2014(9):CD010328. doi: 10.1002/14651858.CD010328.pub2.

    PMID: 25184502BACKGROUND
  • Yoon SM, Ahn SS, Kim KH, Kim YD, Cho JH, Kim DH. Comparative Study of the Outcomes of Percutaneous Endoscopic Lumbar Discectomy and Microscopic Lumbar Discectomy Using the Tubular Retractor System Based on the VAS, ODI, and SF-36. Korean J Spine. 2012 Sep;9(3):215-22. doi: 10.14245/kjs.2012.9.3.215. Epub 2012 Sep 30.

    PMID: 25983818BACKGROUND
  • Parker SL, Mendenhall SK, Godil SS, Sivasubramanian P, Cahill K, Ziewacz J, McGirt MJ. Incidence of Low Back Pain After Lumbar Discectomy for Herniated Disc and Its Effect on Patient-reported Outcomes. Clin Orthop Relat Res. 2015 Jun;473(6):1988-99. doi: 10.1007/s11999-015-4193-1.

    PMID: 25694267BACKGROUND
  • Hebert JJ, Fritz JM, Thackeray A, Koppenhaver SL, Teyhen D. Early multimodal rehabilitation following lumbar disc surgery: a randomised clinical trial comparing the effects of two exercise programmes on clinical outcome and lumbar multifidus muscle function. Br J Sports Med. 2015 Jan;49(2):100-6. doi: 10.1136/bjsports-2013-092402. Epub 2013 Sep 12.

    PMID: 24029724BACKGROUND
  • Barbosa TP, Raposo AR, Cunha PD, Cruz Oliveira N, Lobarinhas A, Varanda P, Direito-Santos B. Rehabilitation after cervical and lumbar spine surgery. EFORT Open Rev. 2023 Aug 1;8(8):626-638. doi: 10.1530/EOR-23-0015.

    PMID: 37526242BACKGROUND
  • Vialle LR, Vialle EN, Suarez Henao JE, Giraldo G. LUMBAR DISC HERNIATION. Rev Bras Ortop. 2015 Nov 16;45(1):17-22. doi: 10.1016/S2255-4971(15)30211-1. eCollection 2010 Jan.

MeSH Terms

Conditions

Intervertebral Disc DisplacementMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A total of 204 patients who underwent surgery for lumbar disc herniation were included and subsequently randomized into five groups. One group served as the control and was advised not to participate in any postoperative exercise. The remaining groups were recommended different exercises, which began at various times after surgery.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 13, 2023

First Posted

September 21, 2023

Study Start

April 1, 2023

Primary Completion

September 1, 2023

Study Completion

September 7, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Locations